International Life Sciences Class II Device Recall

FDA: Device Recalls Class II

Filed March 18th, 2026

Detected March 23rd, 2026

Summary

The FDA has reported a Class II device recall initiated voluntarily by International Life Sciences for their Artelon FlexBand Dynamic Matrix (Ref: 31057). The recall is ongoing due to augmentation devices failing bacterial endotoxin testing. The distribution was worldwide.

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What changed

The FDA has issued a Class II recall for International Life Sciences' Artelon FlexBand Dynamic Matrix (Ref: 31057). The recall, initiated voluntarily by the firm, is ongoing and stems from the augmentation devices failing bacterial endotoxin testing. The product was distributed worldwide, including in the US, Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, the United Kingdom, the United Arab Emirates, and Slovenia.

This recall signifies a potential risk to patient safety due to endotoxin contamination. Companies involved in the distribution or use of this device must ensure they have implemented appropriate recall procedures and are aware of the affected product. While this is a voluntary recall, the FDA's classification indicates a moderate level of health hazard. Compliance officers should monitor the status of this recall and ensure any related inventory is accounted for and handled according to recall protocols.

What to do next

Review distribution records for affected product
Ensure compliance with recall procedures for any affected inventory

Source document (simplified)

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